Transcatheter valve prosthesis and a concurrently delivered sealing component

ABSTRACT

A method of preventing paravalvular leakage includes concurrent delivery of a heart valve prosthesis and an annular sealing component. During delivery, the sealing component is moved from a first position to a second position of the heart valve prosthesis which is longitudinally spaced apart from the first position of the heart valve prosthesis. The sealing component is secured around the heart valve prosthesis at the second position by a contoured outer surface of the heart valve prosthesis. The sealing component may be a flexible ring or may be a cylindrical flexible sleeve having a plurality of ribs longitudinally extending over the cylindrical sleeve. The ribs operate to deploy the sealing component such that at least a portion of the cylindrical sleeve buckles outwardly away from the outer surface of the heart valve prosthesis.

FIELD OF THE INVENTION

The present invention relates to transcatheter valve prostheses andmethods of preventing paravalvular leakage. More specifically, thepresent invention relates to an annular sealing component which isdelivered concurrently with a heart valve prosthesis and extends aroundan outer surface of the heart valve prosthesis to seal gaps between asupport frame of the prosthesis and native valve tissue.

BACKGROUND OF THE INVENTION

A human heart includes four heart valves that determine the pathway ofblood flow through the heart: the mitral valve, the tricuspid valve, theaortic valve, and the pulmonary valve. The mitral and tricuspid valvesare atrioventricular valves, which are between the atria and theventricles, while the aortic and pulmonary valves are semilunar valves,which are in the arteries leaving the heart. Ideally, native leaflets ofa heart valve move apart from each other when the valve is in an openposition, and meet or “coapt” when the valve is in a closed position.Problems that may develop with valves include stenosis in which a valvedoes not open properly, and/or insufficiency or regurgitation in which avalve does not close properly. Stenosis and insufficiency may occurconcomitantly in the same valve. The effects of valvular dysfunctionvary, with regurgitation or backflow typically having relatively severephysiological consequences to the patient.

Recently, flexible prosthetic valves supported by stent structures thatcan be delivered percutaneously using a catheter-based delivery systemhave been developed for heart and venous valve replacement. Theseprosthetic valves may include either self-expanding orballoon-expandable stent structures with valve leaflets attached to theinterior of the stent structure. The prosthetic valve can be reduced indiameter, by crimping onto a balloon catheter or by being containedwithin a sheath component of a delivery catheter, and advanced throughthe venous or arterial vasculature. Once the prosthetic valve ispositioned at the treatment site, for instance within an incompetentnative valve, the stent structure may be expanded to hold the prostheticvalve firmly in place. One example of a stented prosthetic valve isdisclosed in U.S. Pat. No. 5,957,949 to Leonhardt et al. entitled“Percutaneous Placement Valve Stent”, which is incorporated by referenceherein in its entirety. Another example of a stented prosthetic valvefor a percutaneous pulmonary valve replacement procedure is described inU.S. Patent Application Publication No. 2003/0199971 A1 and U.S. PatentApplication Publication No. 2003/0199963 A1, both filed by Tower et al.,each of which is incorporated by reference herein in its entirety.

Although transcatheter delivery methods have provided safer and lessinvasive methods for replacing a defective native heart valve, leakagebetween the implanted prosthetic valve and the surrounding native tissueis a recurring problem. Leakage sometimes occurs due to the fact thatminimally invasive and percutaneous replacement of cardiac valvestypically does not involve actual physical removal of the diseased orinjured heart valve. Rather, the replacement stented prosthetic valve isdelivered in a compressed condition to the valve site, where it isexpanded to its operational state within the mitral valve. Calcified ordiseased native leaflets are pressed to the side walls of the nativevalve by the radial force of the stent frame of the prosthetic valve.These calcified leaflets do not allow complete conformance of the stentframe with the native valve and can be a source of paravalvular leakage(PVL). Significant pressure gradients across the valve cause blood toleak through the gaps between the implanted prosthetic valve and thecalcified anatomy.

Embodiments hereof are related to sealing components extending around anouter surface of the valve prosthesis to seal gaps between the valveprosthesis and native valve tissue.

BRIEF SUMMARY OF THE INVENTION

Embodiments hereof relate to a method of preventing paravalvularleakage. A catheter is percutaneously advanced to a target site. Thecatheter includes a heart valve prosthesis and an annular sealingcomponent, wherein the sealing component is not coupled to the valveprosthesis and the sealing component is positioned around an outersurface of the heart valve prosthesis at a first position thereof. Atleast a portion of the heart valve prosthesis is deployed against nativevalve tissue at the target site. The sealing component is moved to asecond position of the heart valve prosthesis which is longitudinallyspaced apart from the first position of the heart valve prosthesis. Thesealing component is secured around the heart valve prosthesis at thesecond position by a contoured outer surface of the heart valveprosthesis. The sealing component prevents gaps between the valveprosthesis and the native valve tissue to prevent paravalvular leakage.

Embodiments hereof relate to a method of preventing paravalvularleakage. A catheter is percutaneously advanced to a target site. Thecatheter includes a heart valve prosthesis and an annular sealingcomponent encircling an outer surface of the heart valve prosthesis. Thesealing component includes a cylindrical sleeve formed of a flexiblematerial and a plurality of ribs longitudinally extending over thecylindrical sleeve. The sealing component is in a delivery configurationin which the cylindrical sleeve lays flat over the outer surface of theheart valve prosthesis. At least a portion of the heart valve prosthesisis deployed against native valve tissue at the target site. The sealingcomponent is radially expanded to a deployed configuration in which atleast a portion of the ribs are sinusoidal and cause at least a portionof the cylindrical sleeve to buckle outwardly away from the outersurface of the heart valve prosthesis. The sealing component preventsgaps between the valve prosthesis and the native valve tissue to preventparavalvular leakage.

Embodiments hereof relate to a transcatheter valve prosthesis includinga tubular stent having a compressed configuration for delivery within avasculature and an expanded configuration for deployment within a nativeheart valve, a prosthetic valve component disposed within and secured tothe stent, and an annular sealing component coupled to and encircling anouter surface of the tubular stent. The sealing component includes acylindrical sleeve formed of a flexible material and a plurality of ribslongitudinally extending over the cylindrical sleeve. The sealingcomponent has a delivery configuration in which the cylindrical sleeveis lays flat over the outer surface of the heart valve prosthesis and adeployed configuration in which at least a portion of the ribs aresinusoidal and cause at least a portion of the cylindrical sleeve tobuckle outwardly away from the outer surface of the heart valveprosthesis.

BRIEF DESCRIPTION OF DRAWINGS

The foregoing and other features and advantages of the invention will beapparent from the following description of embodiments hereof asillustrated in the accompanying drawings. The accompanying drawings,which are incorporated herein and form a part of the specification,further serve to explain the principles of the invention and to enable aperson skilled in the pertinent art to make and use the invention. Thedrawings are not to scale.

FIG. 1 is a perspective view of an exemplary transcatheter heart valveprosthesis for use in embodiments hereof.

FIG. 2 is a side view illustration of the heart valve prosthesis of FIG.1 implanted within a native valve annulus.

FIG. 3 is a top view of an annular sealing component which may bedelivered concurrently with a transcatheter heart valve prosthesisaccording to embodiments hereof.

FIG. 4 is a side view of a delivery system that may be used to deliverthe annular sealing component of FIG. 3 with the heart valve prosthesisof FIG. 1.

FIGS. 5A-5C illustrate a method of delivering the annular sealingcomponent of FIG. 3 with the heart valve prosthesis of FIG. 1.

FIG. 6 is a side view of a heart valve prosthesis having a tapered outersurface according to another embodiment hereof, the heart valveprosthesis being in a compressed or delivery configuration, wherein thetapered outer surface may be utilized to cause movement of the sealingcomponent of FIG. 3.

FIG. 7 is a side view of the heart valve prosthesis of FIG. 6, the heartvalve prosthesis being in an expanded or delivery configuration.

FIGS. 8A-8B illustrate alternative deployed configurations of heartvalve prostheses having tapered outer surfaces that may be utilized tocause movement of the sealing component of FIG. 3.

FIG. 9 is a perspective view of a sealing component according to anotherembodiment hereof, wherein the sealing component is in a deliveryconfiguration.

FIG. 10 is a side view of the sealing component of FIG. 9, wherein thesealing component is in a deployed configuration.

FIG. 11A-11B illustrate a method of deploying the sealing component ofFIG. 9.

FIG. 12 illustrates a side view of the sealing component of FIG. 9deployed with an aortic valve prosthesis.

FIG. 13 is a perspective view of a sealing component according toanother embodiment hereof, wherein the sealing component is in adelivery configuration.

FIG. 14 is a side view of the sealing component of FIG. 13, wherein thesealing component is in a deployed configuration.

FIGS. 15A-15C illustrate side sectional views of deployment of a sealingcomponent according to another embodiment hereof.

FIGS. 16A-16C illustrate side sectional views of deployment of a sealingcomponent according to another embodiment hereof.

DETAILED DESCRIPTION OF THE INVENTION

Specific embodiments of the present invention are now described withreference to the figures, wherein like reference numbers indicateidentical or functionally similar elements. The terms “distal” and“proximal” in the following description refer to a position or directionrelative to the treating clinician. “Distal” or “distally” are aposition distant from or in a direction away from the clinician.“Proximal” and “proximally” are a position near or in a direction towardthe clinician. The following detailed description is merely exemplary innature and is not intended to limit the invention or the application anduses of the invention. Although the description of the invention is inthe context of treatment of heart valves, the invention may also be usedwhere it is deemed useful in other valved intraluminal sites that arenot in the heart. For example, the present invention may be applied tovenous valves as well. Furthermore, there is no intention to be bound byany expressed or implied theory presented in the preceding technicalfield, background, brief summary or the following detailed description.

FIG. 1 depicts an exemplary transcatheter heart valve prosthesis 100 ina deployed configuration. Heart valve prosthesis 100 is illustratedherein in order to facilitate description of the methods and devices toprevent and/or repair paravalvular leakage according to embodimentshereof. It is understood that any number of alternate heart valveprostheses can be used with the methods and devices described herein.Heart valve prosthesis 100 is merely exemplary and is similar to heartvalve prostheses described in more detail in co-pending patentapplication, U.S. application Ser. No. 13/572,842 filed Aug. 13, 2012,herein incorporated by reference in its entirety, as well as U.S. PatentApplication Publication Nos. 2012/0101572 to Kovalsky et al. and2012/0035722 to Tuval, each of which are herein incorporated byreference in their entirety and illustrate heart valve prosthesesconfigured for placement in a mitral valve.

Heart valve prosthesis 100 includes an expandable stent or support frame102 that supports a prosthetic valve component within the interior ofstent 102. In embodiments hereof, stent 102 is self-expanding to returnto an expanded deployed state from a compressed or constricted deliverystate and may be made from stainless steel, a pseudo-elastic metal suchas a nickel titanium alloy or Nitinol, or a so-called super alloy, whichmay have a base metal of nickel, cobalt, chromium, or other metal.“Self-expanding” as used herein means that a structure/component has amechanical memory to return to the expanded or deployed configuration.Mechanical memory may be imparted to the wire or tubular structure thatforms stent 102 by thermal treatment to achieve a spring temper instainless steel, for example, or to set a shape memory in a susceptiblemetal alloy, such as nitinol, or a polymer, such as any of the polymersdisclosed in U.S. Pat. Appl. Pub. No. 2004/0111111 to Lin, which isincorporated by reference herein in its entirety. Alternatively, heartvalve prosthesis 100 may be balloon-expandable as would be understood byone of ordinary skill in the art.

In the embodiment depicted in FIG. 1, stent 102 of valve prosthesis 100has a deployed stepped configuration including a first section orportion 108 having an expanded diameter D₁ and a second section orportion 110 having an expanded diameter D₂ which is greater thandiameter D₁. Each portion of stent 102, i.e., first portion 108 and/orsecond portion 110, may be designed with a number of differentconfigurations and sizes to meet the different requirements of thelocations in which it may be implanted. When configured as a replacementfor a mitral valve, enlarged second portion 110 functions as an inflowend of heart valve prosthesis 100 and is positioned in the patient'sleft atrium, while first portion 108 functions as an outflow end ofheart valve prosthesis 100 and extends into and anchors within themitral annulus of a patient's left ventricle. Alternatively, heart valveprosthesis may be configured as a replacement for an aortic valve, inwhich first portion 108 functions as an inflow end of heart valveprosthesis 100 and extends into and anchors within the aortic annulus ofa patient's left ventricle, while second portion 110 functions as anoutflow end of heart valve prosthesis 100 and is positioned in thepatient's ascending aorta. Each portion of stent 102 may have the sameor different cross-sections which may be for example circular,ellipsoidal, rectangular, hexagonal, square, or other polygonal shape,although at present it is believed that circular or ellipsoidal may bepreferable when the valve prosthesis is being provided for replacementof the mitral or aortic valves. Stent 102 also includes two generallyU-shaped support or positioning arms 114A, 114B which function toposition and anchor valve prosthesis 100 at a native valve target site.Support arms 114A, 114B are described in more detail in co-pendingpatent application, U.S. application Ser. No. 13/572,842 filed Aug. 13,2012, previously incorporated by reference, as well as U.S. PatentApplication Publication Nos. 2012/0101572 to Kovalsky et al. and2012/0035722 to Tuval, previously incorporated by reference. In oneembodiment, support arms 114A, 114B are pressed or lay flat againststent 102 during delivery thereof and radially expand away from thestent during deployment. In another embodiment hereof, support arms114A, 114B may distally extend from the distal end of the stent when inthe compressed delivery configuration. During deployment, each supportarm bends radially outward and then towards an outer surface of thestent such that it translates more than ninety degrees from thecompressed configuration to proximally extend from the distal end of thestent when the stent is in the deployed configuration, as described inco-pending patent application, U.S. application Ser. No. 13/572,842filed Aug. 13, 2012, previously incorporated by reference.

As previously mentioned, heart valve prosthesis 100 includes aprosthetic valve component within the interior of stent 102. Theprosthetic valve component is capable of blocking flow in one directionto regulate flow there through via valve leaflets 104 that may form abicuspid or tricuspid replacement valve. More particularly, if heartvalve prosthesis 100 is configured for placement within a native valvehaving two leaflets such as the mitral valve, heart valve prosthesis 100includes two valve leaflets 104. If heart valve prosthesis 100 isconfigured for placement within a native valve having three leafletssuch as the aortic, tricuspid, or pulmonary valves, heart valveprosthesis 100 includes three valve leaflets 104. Valve leaflets 104 aresutured or otherwise securely and sealingly attached to the interiorsurface of stent 102 and/or graft material 106 which encloses or linesstent 102 as would be known to one of ordinary skill in the art ofprosthetic tissue valve construction. Referring to FIG. 1, leaflets 104are attached along their bases to graft material 106, for example, usingsutures or a suitable biocompatible adhesive.

Leaflets 104 may be made of pericardial material; however, the leafletsmay instead be made of another material. Natural tissue for replacementvalve leaflets may be obtained from, for example, heart valves, aorticroots, aortic walls, aortic leaflets, pericardial tissue, such aspericardial patches, bypass grafts, blood vessels, intestinal submucosaltissue, umbilical tissue and the like from humans or animals. Syntheticmaterials suitable for use as leaflets 104 include DACRON® polyestercommercially available from Invista North America S.A.R.L. ofWilmington, Del., other cloth materials, nylon blends, polymericmaterials, and vacuum deposition nitinol fabricated materials. Onepolymeric material from which the leaflets can be made is an ultra-highmolecular weight polyethylene material commercially available under thetrade designation DYNEEMA from Royal DSM of the Netherlands. Withcertain leaflet materials, it may be desirable to coat one or both sidesof the leaflet with a material that will prevent or minimize overgrowth.It is further desirable that the leaflet material is durable and notsubject to stretching, deforming, or fatigue.

Graft material 106 may also be a natural or biological material such aspericardium or another membranous tissue such as intestinal submucosa.Alternatively, graft material 106 may be a low-porosity woven fabric,such as polyester, Dacron fabric, or PTFE, which creates a one-way fluidpassage when attached to the stent. In one embodiment, graft material106 may be a knit or woven polyester, such as a polyester or PTFE knit,which can be utilized when it is desired to provide a medium for tissueingrowth and the ability for the fabric to stretch to conform to acurved surface. Polyester velour fabrics may alternatively be used, suchas when it is desired to provide a medium for tissue ingrowth on oneside and a smooth surface on the other side. These and other appropriatecardiovascular fabrics are commercially available from Bard PeripheralVascular, Inc. of Tempe, Ariz., for example.

Stent 102 includes disconnected or decoupled turns or crowns 112 at thetransition area between first and second portions 108, 110, whichadvantageously allows leaflets 104 to extend into second portion 110(and into the left atrium when in situ) rather than be solely located onthe first portion 108 of stent 102 (and into the left ventricle insitu). By locating a portion of the valve leaflets in the left atrium,the required length of first portion 108 is minimized and the length ofthe stent that protrudes into the left ventricle may be reduced. Furtherdescription of stent 102 and advantages thereof are described in U.S.Patent Application Publication No. 2012/0101572 to Kovalsky et al.,previously incorporated by reference.

Delivery of heart valve prosthesis 100 may be accomplished via apercutaneous transfemoral approach or a transapical approach directlythrough the apex of the heart via a thoracotomy, or may be positionedwithin the desired area of the heart via different delivery methodsknown in the art for accessing heart valves. During delivery, ifself-expanding, the prosthetic valve remains compressed until it reachesa target diseased native heart valve, at which time the heart valveprosthesis 100 can be released from the delivery catheter and expandedin situ via self-expansion. The delivery catheter is then removed andheart valve prosthesis 100 remains deployed within the native targetheart valve. Alternatively, heart valve prosthesis 100 may beballoon-expandable and delivery thereof may be accomplished via aballoon catheter as would be understood by one of ordinary skill in theart.

FIG. 2 is a side view illustration of heart valve prosthesis 100implanted within a native heart valve, which is shown in section, havingnative leaflets L_(N). Heart valve prosthesis 100 is shown deployedwithin a native mitral valve, with first portion 108 extending into theleft ventricle and enlarged second portion 110 extending into the leftatrium. When heart valve prosthesis 100 is deployed within the valveannulus of a native heart valve, stent 102 expands within native valveleaflets L_(N) of the patient's defective valve, retaining the nativevalve leaflets in a permanently open state. The native valve annulus mayinclude surface irregularities on the inner surface thereof, and as aresult one or more gaps or cavities/crevices may be present or may formbetween the perimeter of heart valve prosthesis 100 and the native valveannulus. For example, calcium deposits may be present on the nativevalve leaflets (e.g., stenotic valve leaflets) and/or shape differencesmay be present between the native heart valve annulus and prosthesis100. More particularly, in some cases native annuli are not perfectlyrounded and have indentations corresponding to the commissural points ofthe native valve leaflets. As a result, a prosthesis having anapproximately circular shape does not provide an exact fit in a nativevalve. These surface irregularities, whatever their underlying cause,can make it difficult for conventional prosthetic valves to form a bloodtight seal between the prosthetic valve and the inner surface of thevalve annulus, causing undesirable paravalvular leakage and/orregurgitation at the implantation site.

Embodiments hereof relate to methods for delivering an annular sealingcomponent 320, shown in FIG. 3, concurrently with heart valve prosthesis100. Annular sealing component 320 is a flexible ring that closes and/orprevents gaps between the valve prosthesis and the native valve tissueto repair and/or prevent paravalvular leakage. More particularly, duringdelivery thereof, sealing component 320 is not coupled to heart valveprosthesis 100 and is positioned around or adjacent to an outer surfaceor perimeter of the heart valve prosthesis at a first position thereof.At least a portion of heart valve prosthesis 100 is deployed againstnative valve tissue at the target site. Sealing component 320 is movedto a second position of heart valve prosthesis 100 which islongitudinally spaced apart from the first position. Sealing component320 is secured around the heart valve prosthesis at the second positionby a contoured outer surface of the deployed heart valve prosthesis.

Annular sealing component 320 provides a continuous circumferential sealaround heart valve prosthesis 100 to prevent blood flow between theouter surface or perimeter of heart valve prosthesis 100 and the nativeheart valve. Annular sealing component 320 may be formed from a pliableand compressible polymer material such as polyurethane or silicone or anelastic material. “Elastic” as used in this context includes materialsthat may be stretched or elongated during deployment of heart valveprosthesis 100, while also having sufficient resiliency to conform tothe outer surface of the heart valve prosthesis. Suitable polymermaterials include polymer materials such as polyurethane or silicone, aswell as biological or natural materials such as pericardium or anothermembranous tissue such as intestinal submucosa. The elastic annularsealing component 320 has sufficient resiliency to conform to and besecured over the outer surface of the heart valve prosthesis, but doesnot exert an amount of force that would result in constriction orreduction of the inner diameter of the heart valve prosthesis. Othersuitable material examples for annular sealing component 320 includetissue, compressible foam materials, fabric, or a swellable materialthat collapses easily and expands to a larger volume after implantation,such as but not limited to hydrogel or a collagen foam/sponge similar tothe material commercially available under the trademark Angioseal.

In another embodiment hereof, annular sealing component 320 may be ahollow sac or membrane previously filled with an inflation medium.Suitable materials for the membrane include flexible/pliable polymerssuch as ePTFE, polyurethane, or silicone and suitable inflation mediuminclude but are not limited to gels, biocompatible polymers includingcurable polymers, gases, saline, blood, and the like. In anotherembodiment, annular sealing component 320 may be a hollow sac ormembrane that is filled with an inflation medium that is deliveredthrough an inflation lumen (not shown) of delivery system 422. In thisembodiment, the inflation lumen of the delivery system need be in fluidcommunication with the lumen of the hollow sac or membrane of annularsealing component 320 via one or more inflation ports (not shown). Asthe inflation medium is delivered, annular sealing component 320radially expands into contact with native tissue such that it engagesand conforms to the inner surface of the valve annulus including anysurface irregularities that may be present. The annular sealingcomponent 320 is inflated to such an extent that a sufficient orsatisfactory seal is created between prosthesis 100 and the innersurface of the native valve annulus. The expanded annular sealingcomponent 320 is compliant and fills any/all gaps existing between theprosthesis and the native valve tissue but does not reduce the innerdiameter of prosthesis 100. The inflation ports of annular sealingcomponent 320 may be sealed off to maintain constant pressure within theannular sealing component. In an embodiment, injectable, self-expandinggel or foam may be delivered to fill the inflation ports. In anotherembodiment, the inflation ports may include one-way check valves thatallow passage of the inflation medium and prevent leakage/removal of theinflation medium after delivery thereof.

FIG. 4 illustrates a side view of a delivery system 422 that may beutilized to deliver annular sealing component 320 concurrently withheart valve prosthesis 100. Delivery system 422 includes an outer shaft428 having a proximal end 434 and a distal end 436, an intermediateshaft 426 having a proximal end 432 and a distal end 438, and an innershaft 424 having a proximal end 430 and a distal end 440. Intermediateshaft 426 is slidingly disposed over or moveable in an axial directionalong and relative to inner shaft 424, and outer shaft 428 is slidinglydisposed over or moveable in an axial direction along and relative tointermediate shaft 426. Inner shaft 424 may define a guidewire lumen(not shown) for receiving a guidewire (not shown) there through suchthat inner shaft 424 may be advanced over an indwelling guidewire totrack delivery system 422 to the target site. Intermediate shaft 426 isprovided to cover and radially restrain heart valve prosthesis 100 (notshown in FIG. 4), which is mounted on a distal portion of inner shaft424, in a compressed or delivery configuration when delivery system 422is tracked through a body lumen to the deployment site. Outer shaft 428is utilized to push sealing component 320 into a desired position orlocation along heart valve prosthesis 100, as will be described in moredetail herein.

FIGS. 5A-5C illustrate a method of using delivery system 422 to deliversealing component 320 concurrently with heart valve prosthesis 100. Onlya distal portion of delivery system 422 is shown in FIGS. 5A-5C.Delivery system 422 is delivered to the target site with heart valveprosthesis 100 in the compressed delivery configuration via intermediateshaft 426. Once is position, intermediate shaft 426 is partiallyretracted to deploy and radially expand support arms 114A, 114B of heartvalve prosthesis 100 as shown in FIG. 5A. As previously stated, in oneembodiment, support arms 114A, 114B are pressed or lay flat againststent 102 during delivery thereof and radially expand away from thestent during deployment. In another embodiment hereof, support arms114A, 114B distally extend from the distal end of the stent when in thecompressed delivery configuration. During deployment, each support armbends radially outward and then towards an outer surface of the stentsuch that it translates more than ninety degrees from the compressedconfiguration to proximally extend from the distal end of the stent whenthe stent is in the deployed configuration. Stent 102 remains coveredand constrained via intermediate shaft 426. Sealing component 320 is notcoupled to heart valve prosthesis 100 and is positioned around oradjacent to an outer surface or perimeter of the heart valve prosthesisat a first position thereof. The first position is proximal or adjacentto second portion 110 of heart valve prosthesis 100, which at this pointin the method is still radially constrained via intermediate shaft 426.

After support arms 114A, 114B are deployed, outer shaft 428 is utilizedto longitudinally translate or move sealing component 320 relative toheart valve prosthesis 100. Distal end 438 contacts sealing component320 and as outer shaft 428 is distally advanced, distal end 438 pushessealing component 320 over intermediate shaft 426, which still radiallyconstrains stent 102 of heart valve prosthesis 100. Sealing component320 is distally advanced until it extends around first portion 108 ofheart valve prosthesis 100 and abuts against deployed support arms 114A,114B, as shown in FIG. 5B. In another embodiment hereof (not shown),sealing component 320 may be temporarily coupled or attached to distalend 438 of outer shaft 428 via a suture or clip so that the sealingcomponent is concurrently distally advanced with outer shaft 428. Oncethe sealing component is positioned as desired, it may be detached fromdistal end 438 of outer shaft 428 by cutting the suture or clip ortwisting/rotating outer shaft 428 to severe the connection between theouter shaft and the sealing component so that the outer shaft may bewithdrawn while leaving the sealing component in place.

After sealing component 320 is positioned against support arms 114A,114B, outer shaft 428 and intermediate shaft 426 are proximallyretracted in order to deploy stent 102 of heart valve prosthesis 100 asshown in FIG. 5C. If first portion 108 of heart valve prosthesis 100radially expands to a greater diameter during deployment, sealingcomponent 320 which was previously positioned over first portion 108radially expands with deployment of stent 102 due to the flexible and/orelastic properties of sealing component 320. After deployment of stent102, sealing component 320 is positioned around and conforms to oragainst the outer surface or perimeter of heart valve prosthesis, overfirst portion 108 of heart valve prosthesis 100, to prevent paravalvularleakage in situ. Sealing component 320 is secured around heart valveprosthesis 100 without being coupled thereto due to a contoured orshaped outer surface 518 of the heart valve prosthesis. Moreparticularly, in this embodiment, first portion 108 defines a waist orreduced diameter section between deployed support arms 114A, 114B andenlarged deployed second portion 110. With sealing component 320positioned over first portion 108, the sealing component is effectivelysandwiched or lodged onto the waist or reduced diameter section betweendeployed support arms 114A, 114B and enlarged deployed second portion110. In situ, annular sealing component 320 may be positioned at thevalve annulus, slightly above the valve annulus, slightly below thevalve annulus, or some combination thereof. Sealing component 320extends in a radially outward direction relative to the outer surface ofheart valve prosthesis 100. An expanded or deployed outer diameter ofsealing component 320 is greater than the expanded outer diameter offirst portion 108 of stent 102. When deployed, sealing component 320radially expands into and substantially fills any/all gaps orcavities/crevices between the outer surface of stent 102 and nativevalve tissue. “Substantially” as utilized herein means that blood flowthrough the target gap or cavity is occluded or blocked, or statedanother way blood is not permitted to flow there through.

FIGS. 6-7 illustrate another embodiment hereof in which radial expansionof the stent component causes relocation or movement of the sealingcomponent, thereby eliminating the need for an outer sheath which pushesthe sealing component into place as described above. More particularly,FIG. 6 illustrates a heart valve prosthesis 600 in a delivery orcompressed configuration and FIG. 7 illustrates heart valve prosthesis600 in an expanded or deployed configuration. Heart valve prosthesis 600includes a self-expanding stent or frame 602 which has a first end 656and a second end 658. In the delivery configuration of FIG. 6, heartvalve prosthesis 600 is cylindrical and has a compressed outer diameterD₁. Annular sealing component 620, which is similar to sealing component320 described above, is positioned around first end 656 of stent 602.

When deployed, as shown in FIG. 7, heart valve prosthesis includes afirst portion 650 having a deployed outer diameter D₂, a second portion654 having a deployed outer diameter D₃, and an intermediate portion orwaist 652 having a deployed outer diameter D₄ that is positioned betweenthe first and second portions. Deployed outer diameter D₄ of theintermediate portion is less than deployed outer diameter D₂ of thefirst portion 650 and is less than deployed outer diameter D₃ of thesecond portion 654. Deployed outer diameter D₂ of the first portion 650may be greater than, less than, or equal to the deployed outer diameterD₃ of the second portion 654. A contoured outer surface 618 of heartvalve prosthesis 600 includes a gradual and continuous taper 670 alongfirst portion 650 between first end 656 and waist 652. Radial expansionof stent 602 causes sealing component 620 to slide along the taperedouter surface of first portion 650 of heart valve prosthesis first end656 to waist 652. Due to the shape or profile of first portion 650, thedeployment dynamics of stent 602 result in active movement ortranslation of sealing component 620 towards waist 652. In addition,similar to sealing component 320 and first portion 108 of heart valveprosthesis 100, sealing component 620 is secured around heart valveprosthesis 600 without being coupled thereto because due to waist 652which has a reduced diameter relative to first and second portions 652,654. Sealing component 620 is effectively sandwiched or lodged betweendeployed portions 650, 654 of heart valve prosthesis 600. As such, inthis embodiment, sealing component 620 moves into position due to taper670 of contoured outer surface 618 and then remains secured in positiondue to the reduced diameter of waist 652 of contoured outer surface 618.

In one embodiment, the prosthetic valve component (not shown in FIG. 6)of heart valve prosthesis 600 is disposed within waist or intermediateportion 652 of heart valve prosthesis 600. In another embodiment, theprosthetic valve component may be disposed within either first portion650 or second portion 654 of heart valve prosthesis 600.

Each portion of heart valve prosthesis 600, i.e., first portion 650,waist 652, and second portion 654, may be designed with a number ofdifferent configurations and sizes, i.e., diameters and/or lengths, tomeet the different requirements of the locations in which it may beimplanted. In addition, although first portion 650 of heart valveprosthesis 600 is required to have a tapered outer surface, the deployedconfiguration depicted in FIG. 7 is exemplary. FIGS. 8A and 8Billustrate other exemplary deployed configurations of a heart valveprosthesis having a contoured outer surface with a taper to move andposition a sealing component as well as a reduced diameter waist portionto secure the sealing component in place. More particularly, FIG. 8Aillustrates a heart valve prosthesis 800A having a first portion 850Awith a tapered outer surface, an intermediate portion or waist 852A, anda second portion 854A with a tapered outer surface. Radial expansion offirst portion 850A or second portion 854A may cause a sealing component(not shown in FIG. 8A) mounted on heart valve prosthesis 800A to movetowards waist 852A, which then functions to secure the sealing componentinto place. FIG. 8B illustrates a heart valve prosthesis 800B having afirst portion 850B with a tapered outer surface, an intermediate portionor waist 852B, and a bulbous second portion 854B. Radial expansion offirst portion 850B causes a sealing component (not shown in FIG. 8B)mounted on heart valve prosthesis 800B to move towards waist 852B, whichthen functions to secure the sealing component into place.

FIGS. 9 and 10 illustrate another embodiment of a sealing componentwhich is delivered concurrently with a heart valve prosthesis. Moreparticularly, FIG. 9 illustrates a sealing component 920 in a compressedor delivery configuration while FIG. 10 illustrates sealing component920 in a deployed or expanded configuration. Sealing component 920includes a generally tubular or cylindrical sleeve 972 and a pluralityof longitudinally-extending ribs 974 coupled to a surface of sleeve 972.Cylindrical sleeve 972 has a first end 978 and a second end 980, anddefines a lumen 976 there through. Suitable materials for cylindricalsleeve 972 include but are not limited to a low-porosity woven fabric,such as polyester, PTFE, ePTFE, or polyurethane. Porous materials suchas but not limited to closed or open celled sponges or foamsadvantageously provide a medium for tissue ingrowth. Further,cylindrical sleeve 972 may be pericardial tissue or may be a knit orwoven polyester, such as a polyester or PTFE knit, both of which providea medium for tissue ingrowth and have the ability to stretch to conformto a curved surface. Polyester velour fabrics may alternatively be used,such as when it is desired to provide a medium for tissue ingrowth onone side and a smooth surface on the other side.

Each longitudinally-extending rib 974 extends from first end 978 ofsleeve 972 to second end 980 of sleeve 972 and are formed from strandsof a shape memory material having a sinusoidal pattern including aplurality of turns or bends 982 having opposing orientations and aplurality of segments 984 with bends 982 being formed between a pair ofadjacent segments 984 as shown in FIG. 10. In the embodiment depicted inFIG. 10, ribs 974 each include five turns or bends 982. However, itwould be obvious to one of ordinary skill in the art that thelongitudinally-extending ribs may include a higher or lower number ofbends. Conformability of the ribs increases with a higher or increasednumber of bends; however, the ribs are more radially-compressible orcollapsible for delivery with a lower or decreased number of bends. Aswill be described in more detail below, when deployed, ribs 974 returnto their preset expanded or deployed shape because they are formed froma self-expanding material which is configured to return to an expandeddeployed state from a compressed or constricted delivery state and maybe made from stainless steel, a pseudo-elastic metal such as a nickeltitanium alloy or Nitinol, or a so-called super alloy, which may have abase metal of nickel, cobalt, chromium, or other metal. Each rib 974 maybe coupled to cylindrical sleeve 972 via stitches or other mechanicalmethod.

With additional reference to FIGS. 11A and 11B, sealing component 920 ispositioned over the outer surface of heart valve prosthesis 100 withfirst end 978 adjacent to support arms 114A, 114B. Although describedfor use with heart valve prosthesis 100, sealing component 920 may beutilized with heart valve prostheses of other configurations as will bedescribed in more detail herein. In the compressed deliveryconfiguration shown in FIG. 9 and FIG. 11A, sealing component 920 isflat against or stretched over the heart valve prosthesis, which ismounted over an inner shaft 1126 having a distal end 1140 as understoodby one of ordinary skill in the art, and both the sealing component andthe heart valve prosthesis are radially compressed by an outer shaft orcover 1128 having a distal end 1138. As such, when in the deliveryconfiguration, sealing component 920 has a compressed diameter D₁ andribs 974 are generally straightened or stretched out. When it is desiredto deploy both the sealing component and the heart valve prosthesis,cover 1128 is proximally retracted and sealing component 920 and heartvalve prosthesis 100 are allowed to self-expand to their deployedconfiguration as shown in FIG. 11B. When released from cover 1128, ribs974 assume their deployed or expanded configuration in which ribs 974are sinusoidal and sealing component 920 expands to a deployed diameterD₂ which is greater than the compressed diameter D₁. When ribs 974assume their sinusoidal deployed configuration, the material ofcylindrical sleeve 972 buckles outwardly away from the outer surface ofheart valve prosthesis 100 similar to an accordion. Stated another way,cylindrical sleeve 972 collapses or crumples resulting in portionsthereof which bulge or bend in a radial direction away from the outersurface of heart valve prosthesis 100.

Similar to sealing element 320, sealing component 920 is positionedaround the outer surface or perimeter of heart valve prosthesis 100,over first portion 108 of heart valve prosthesis 100, to preventparavalvular leakage in situ. In this embodiment, sealing component 920is secured around heart valve prosthesis 100 without being coupledthereto due to the contoured outer surface which effectively sandwichesor lodges the sealing element between the deployed support arms 114A,114B and enlarged deployed second portion 110 of heart valve prosthesis100. In addition, sealing element 920 may be used with heart valveprostheses including other contoured outer surfaces that include a waistportion of reduced diameter, such as but not limited to the prosthesesdepicted in FIGS. 8A and 8B, for securing the sealing element intoplace.

In another embodiment hereof, a portion of sealing element 920 may becoupled to a heart valve prosthesis for securement thereto rather thanutilizing a contoured outer surface of the heart valve prosthesis forsecurement thereto. More particularly, as shown in FIG. 12, a sealingelement 1220, which is similar to sealing element 920, is shown for usewith a heart valve prosthesis 1200 having a stent or frame 1202 which isconfigured to be an aortic valve prosthesis as described in more detailin U.S. Patent Application Pub. No. 2011/0172765 to Nguyen et al.,herein incorporated by reference in its entirety. Sealing component 1220has a generally tubular or cylindrical sleeve 1272 and a plurality oflongitudinally-extending ribs 1274, and is shown in its deployedconfiguration around heart valve prosthesis 1200 which is deployedwithin a native aortic valve. Heart valve prosthesis 1200 does notinclude a contoured outer surface for securing the sealing component,but rather a first end or edge 1278 of sealing member 1220 is coupled toheart valve prosthesis 1200. The remaining length, as well as a secondend 1280, is not coupled to heart valve prosthesis 1200 because thesealing component is required to be free to buckle into the deployedconfiguration.

FIGS. 13-14 illustrate a related embodiment in which a sealing component1320 includes longitudinally-extending ribs 1374 that are cinched totransform sealing component 1320 from a compressed or deliveryconfiguration shown in FIG. 13 to a deployed or expanded configurationshown in FIG. 14. Similar to sealing component 920, sealing component1320 includes a generally tubular or cylindrical sleeve 1372 which has afirst end 1378, a second end 1380, and defines a lumen 1376 therethrough. Cylindrical sleeve 1372 is similar to cylindrical sleeve 972but in this embodiment, rather than being self-expanding, eachlongitudinally-extending rib 1374 is a monofilament strand or braidedstrands of material that is woven or stitched through cylindrical sleeve1372. Suitable materials for ribs 1374 include suture-type materialssuch as but not limited to polymeric materials such as nylon, PTFE, orhigh density polyethylene, as well as metallic materials. Moreparticularly, each longitudinally-extending rib 1374 is coupled tocylindrical sleeve 1372 at first end 1378 of sealing component 1320 andeach rib extends longitudinally and passes through cylindrical sleeve1372 in a running stitch. Each longitudinally-extending rib 1374proximally extends beyond second end 1380 of sealing component 1320through a tubular shaft 1386, which is a component of the deliverysystem as will be explained in more detail below, such that a proximalend thereof (not shown) may be controlled by the user.

When it is desired to deploy sealing component 1320, an enlarged distalend 1388 of shaft 1386 is proximally advanced over second end 1380 ofsealing member 1320 such that a first portion 1490 of sealing component1320 is securely held within distal end 1388 of shaft 1386 and a secondportion 1492 of sealing component 1320 extends distally beyond distalend 1388 of shaft 1386. Longitudinally-extending ribs 1374 are stretchedor pulled until taut in order to remove the slack from ribs 1374. Whenpulled or tightened, the portions of ribs 1374 which are securely heldwithin distal end 1388 of shaft 1386 are generally straightened or tautwhile the portion of ribs which distally extend beyond distal end 1388of shaft 1386 are cinched. As ribs 1374 are pulled, first end 1378 ofsealing member 1320, which is coupled to ribs 1374, is also pulled in aproximal direction and the material of cylindrical sleeve 1372 bucklesoutwardly similar to an accordion. Stated another way, second portion1492 of cylindrical sleeve 1372 collapses or crumples resulting inportions thereof which bulge or bend in an outward radial direction.Deployment of sealing component 1320 and the heart valve prosthesis maybe simultaneous or at the same time, or alternatively, may beincremental in which a first or distal portion of the heart valveprosthesis is deployed, then sealing component 1320 is deployed, andlastly the remainder or proximal portion of the heart valve prosthesisis deployed. After second portion 1492 of cylindrical sleeve 1372deploys as desired, a slip knot or mechanical stopper such as a ferrelor washer (not shown) may be delivered adjacent to the bulged or bentportions of ribs 1374 and a cutting component (not shown), which may beintegrated into the delivery system or may be a separate device, may beadvanced to cut or sever ribs 1374 adjacent to first end 1380 of sealingcomponent 1320. Although not required since sealing member 1320 issandwiched between the deployed prosthesis and the surrounding anatomy,the slip knot or mechanical stopper assists in preventing deployedsecond portion 1492 of cylindrical sleeve 1372 from straightening out.

As described with respect to sealing component 920, sealing component1320 may or may not be coupled to a heart valve prosthesis dependingupon the prosthesis configuration. In one embodiment, sealing element1320 may be secured around a heart valve prosthesis without beingcoupled thereto if it is effectively sandwiched or lodged on a waistportion of reduced diameter of a contoured outer surface of the heartvalve prosthesis. Alternatively, second end 1380 of sealing component1320 may be coupled to a portion of the heart valve prosthesis. Theremaining length, as well as first end 1378, is not coupled to heartvalve prosthesis because the sealing component is required to be free tobuckle into the deployed configuration.

FIGS. 15A-15C illustrates a sealing component 1520 which is similar instructure to sealing component 1320 but is deployed to the buckledconfiguration via the delivery system in a different manner. Althoughonly a distal portion of the delivery system is shown in FIGS. 15A-15C,the delivery system includes an inner shaft 1524 and a graft cover orshaft 1586 slidingly disposed over the inner shaft. A heart valveprosthesis 1500 is disposed over a distal portion of inner shaft 1524.Sealing component 1520 includes a generally tubular or cylindricalsleeve 1572 which has a first end 1578, a second end 1580, and defines alumen (not shown) there through. In one embodiment, first end 1578 ofsleeve 1572 may be coupled to a portion of heart valve prosthesis 1500.The remaining length, as well as second end 1580, is not coupled toheart valve prosthesis because the sealing component is required to befree to buckle into the deployed configuration. In another embodiment,sealing element 1520 may be disposed around a heart valve prosthesiswithout being coupled thereto.

Sealing component 1520 includes longitudinally-extending ribs 1574 thatare cinched or buckled to transform sealing component 1520 from acompressed or delivery configuration shown in FIG. 15A to a deployed orexpanded configuration shown in FIG. 15C. Similar to ribs 1374, eachlongitudinally-extending rib 1574 is a monofilament strand or braidedstrands of material that is woven or stitched through cylindrical sleeve1572. Each longitudinally-extending rib 1574 is coupled to cylindricalsleeve 1572 at second end 1580 of sealing component 1520 and each ribextends longitudinally and passes through cylindrical sleeve 1572 in arunning stitch. Each longitudinally-extending rib 1574 distally extendsbeyond first end 1578 of sealing component 1520 and is coupled to adistal end 1588 of a graft cover or shaft 1586, which is a component ofthe delivery system having a proximal end (not shown) which iscontrolled by the user. When secured within graft cover 1586, ribs 1574are generally straightened or taut.

When it is desired to deploy sealing component 1520, graft cover 1586 isproximally retracted as shown in FIG. 15B. As it is released from graftcover 1586, heart valve prosthesis 1500 as well as cylindrical sleeve1572 disposed around the prosthesis radially expands into appositionwith the surrounding anatomy (not shown). In addition to radialexpansion, retraction of graft cover 1586 results in deployment ofsealing component 1520 because ribs 1574 are cinched by the movement ofgraft cover 1586. More particularly, since the distal ends of ribs 1574are coupled to distal end 1588 of graft cover 1586, retraction of thegraft cover pulls the distal ends of ribs 1574 in a proximal directionwhile pulling the length of ribs 1574 which are woven through sleeve1572 in a distal direction. With first end 1578 of sleeve 1572 coupledto prosthesis 1500, pulling the length of ribs 1574 which are woventhrough sleeve 1572 in a distal direction results in second end 1580 ofsleeve 1572 moving or sliding in a distal direction and the material ofcylindrical sleeve 1572 buckles outwardly similar to an accordion.Stated another way, the material of cylindrical sleeve 1572 collapses orcrumples resulting in portions thereof which bulge or bend in an outwardradial direction. The same effect occurs if first end 1578 of sleeve1572 is not coupled to prosthesis 1500 because first end 1578effectively becomes wedged or sandwiched between the anatomy and thedeployed distal end of heart valve prosthesis when graft cover 1586 isproximally retracted over the first end 1578. When it is effectivelywedged between the surrounding anatomy and the deployed prosthesis,first end 1578 is stationary and further retraction of graft cover 1586results in pulling second end 1580 of sleeve 1572 and cinching ribs 1574as described above.

After sealing component 1520 is deployed, ribs 1574 may be detached fromdistal end 1588 of graft cover 1586 as shown in FIG. 15C by cutting theribs via an integrated or separate cutting mechanism (not shown) or bytwisting/rotating graft cover 1586 to severe the connection between thegraft cover and the sealing component so that graft cover 1586 may bewithdrawn while leaving the sealing component in place.

FIGS. 16A-16C illustrates a sealing component 1620 which is deployed tothe buckled configuration similar to sealing component 1520 except thatthe delivery system utilizes a two-part graft cover for deployment. Moreparticularly, the delivery system includes an inner shaft 1624 and aheart valve prosthesis 1600 disposed over a distal portion of innershaft 1524. A two-part graft cover or shaft of the delivery systemincludes a first tubular shaft 1686A slidingly disposed over inner shaft1624 as well as the proximal portion of heart valve prosthesis 1600 anda second tubular shaft 1686B slidingly disposed over the distal portionof heart valve prosthesis 1600. In the delivery configuration of FIG.16A, sealing component 1620 is sandwiched between the distal portion ofheart valve prosthesis 1600 and second tubular shaft 1686B. Sealingcomponent 1620 includes a generally tubular or cylindrical sleeve 1672which has a first end 1678, a second end 1680, and defines a lumen (notshown) there through. In one embodiment, second end 1680 of sleeve 1672is coupled to a portion of heart valve prosthesis 1600. The remaininglength, as well as first end 1678, is not coupled to heart valveprosthesis because the sealing component is required to be free tobuckle into the deployed configuration. In another embodiment, sealingelement 1620 may be disposed around a heart valve prosthesis withoutbeing coupled thereto.

Sealing component 1620 includes longitudinally-extending ribs 1674 thatare cinched or buckled to transform sealing component 1620 from acompressed or delivery configuration shown in FIG. 16A to a deployed orexpanded configuration shown in FIG. 16C. Similar to ribs 1574, eachlongitudinally-extending rib 1674 is a monofilament strand or braidedstrands of material that is woven or stitched through cylindrical sleeve1672. Each longitudinally-extending rib 1674 is coupled to cylindricalsleeve 1672 at first end 1678 of sealing component 1620 and each ribextends longitudinally and passes through cylindrical sleeve 1672 in arunning stitch. Each longitudinally-extending rib 1674 extends beyondsecond end 1680 of sealing component 1820 and is coupled to a distal end1888 of a second tubular shaft 1686B. When secured within second tubularshaft 1686B, ribs 1674 are generally straightened or taut.

When it is desired to deploy sealing component 1620, second tubularshaft 1686B is proximally retracted as shown in FIG. 16B. As it isreleased from second tubular shaft 1686B, heart valve prosthesis 1600 aswell as cylindrical sleeve 1672 disposed around the prosthesis radiallyexpands into apposition with the surrounding anatomy (not shown). Inaddition to radial expansion, retraction of second tubular shaft 1686Bresults in deployment of sealing component 1620 because ribs 1674 arecinched by the movement of second tubular shaft 1686B. Moreparticularly, since the distal ends of ribs 1674 are coupled to distalend 1688 of second tubular shaft 1686B, retraction of second tubularshaft 1686B pulls the distal ends of ribs 1674 in a proximal directionwhile pulling the length of ribs 1674 which are woven through sleeve1672 in a distal direction. With second end 1680 of sleeve 1672 coupledto prosthesis 1600, pulling the length of ribs 1674 which are woventhrough sleeve 1672 in a distal direction results in first end 1678 ofsleeve 1672 moving or sliding in a distal direction and the material ofcylindrical sleeve 1672 buckles outwardly similar to an accordion.Stated another way, the material of cylindrical sleeve 1672 collapses orcrumples resulting in portions thereof which bulge or bend in an outwardradial direction. The same effect occurs if second end 1680 of sleeve1672 is not coupled to prosthesis 1600 because second end 1680effectively becomes wedged or sandwiched between the anatomy and thedeployed distal end of heart valve prosthesis when second tubular shaft1686B is proximally retracted over the second end 1680. When it iseffectively wedged between the surrounding anatomy and the deployedprosthesis, second end 1680 is stationary and further retraction ofsecond tubular shaft 1686B results in pulling first end 1678 of sleeve1672 and cinching ribs 1674 as described above.

After sealing component 1620 is deployed, ribs 1674 may be detached fromdistal end 1688 of second tubular shaft 1686B as shown in FIG. 16C bycutting the ribs via an integrated or separate cutting mechanism (notshown) or by twisting/rotating second tubular shaft 1686B to severe theconnection between the graft cover and the sealing component so thatsecond tubular shaft 1686B may be withdrawn while leaving the sealingcomponent in place. In addition, first tubular shaft 1686A is proximallyretracted to deploy the proximal portion of heart valve prosthesis 1600.

While various embodiments according to the present invention have beendescribed above, it should be understood that they have been presentedby way of illustration and example only, and not limitation. It will beapparent to persons skilled in the relevant art that various changes inform and detail can be made therein without departing from the spiritand scope of the invention. Thus, the breadth and scope of the presentinvention should not be limited by any of the above-described exemplaryembodiments, but should be defined only in accordance with the appendedclaims and their equivalents. It will also be understood that eachfeature of each embodiment discussed herein, and of each reference citedherein, can be used in combination with the features of any otherembodiment. All patents and publications discussed herein areincorporated by reference herein in their entirety.

What is claimed is:
 1. A method of preventing paravalvular leakage, themethod comprising the steps of: percutaneously advancing a catheter to atarget site, wherein the catheter includes a heart valve prosthesis andan annular sealing component, wherein the heart valve prosthesisincludes a self-expanding tubular stent component defining a lumentherethrough and a prosthetic valve component disposed within andsecured to the stent component, the stent component including a firstportion, a second portion, and an intermediate waist portion positionedbetween the first and second portions, wherein the sealing component isnot coupled to the heart valve prosthesis and is positioned around anouter surface of the heart valve prosthesis at a first position on thefirst portion of the heart valve prosthesis; deploying at least aportion of the heart valve prosthesis against native valve tissue at atarget site; moving the sealing component relative to the heart valveprosthesis from the first position to a second position on theintermediate waist portion of the heart valve prosthesis which islongitudinally spaced apart from the first position of the heart valveprosthesis, wherein the sealing component is secured around the heartvalve prosthesis at the second position by a contoured outer surface ofthe heart valve prosthesis and the sealing component prevents gapsbetween the valve prosthesis and the native valve tissue to preventparavalvular leakage; wherein a deployed diameter of the intermediatewaist portion is less than a deployed diameter of the first portion andis less than a deployed diameter of the second portion and the contouredouter surface of the heart valve prosthesis includes a gradual andcontinuous taper between the first portion and the intermediate waistportion; wherein the step of deploying at least a portion of the heartvalve prosthesis includes radially expanding the stent component whereinthe radial expansion of the stent component causes the sealing componentto slide along the taper of the contoured outer surface.
 2. The methodof claim 1, wherein the sealing component is formed from a materialselected from a group consisting of cloth, foam, or a polymer.
 3. Themethod of claim 1, wherein the prosthetic valve component is disposedwithin the intermediate portion of the stent component.
 4. A method ofpreventing paravalvular leakage, the method comprising the steps of:percutaneously advancing a catheter to a target site, wherein thecatheter includes a heart valve prosthesis and an annular sealingcomponent, the heart valve prosthesis including a self-expanding tubularstent component including a first portion, a second portion, and anintermediate waist portion positioned between the first and secondportions and a prosthetic valve component disposed within and secured tothe stent component, wherein the sealing component is not coupled to theheart valve prosthesis and is positioned around an outer surface of theheart valve prosthesis at the first portion of the stent component; anddeploying the heart valve prosthesis by radially expanding the stentcomponent against native valve tissue at the target site, wherein adeployed diameter of the intermediate waist portion is less than adeployed diameter of the first portion and is less than a deployeddiameter of the second portion and a contoured outer surface of thestent component includes a gradual and continuous taper between thefirst portion and the intermediate waist portion, and wherein radialexpansion of the stent component causes the sealing component to moverelative to the heart valve prosthesis and slide in a longitudinaldirection along the taper of the contoured outer surface from the firstportion of the stent component to the intermediate waist portion of thestent component.
 5. The method of claim 4, wherein the sealing componentis secured around the heart valve prosthesis at the intermediate waistportion of the stent component due to the contoured outer surface of thestent component.